外派临床监察员
希奥莱姆医药科技咨询（上海）有限公司
- 公司规模：500-1000人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2013-11-30
- 工作地点：武汉
- 招聘人数：1
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：临床研究员
职位描述
职务工作地点为指定的著名外企药厂
JOB RESPONSIBILITIES
1.List the primary responsibilities(5-7), in order of importance to the business.
2.Identifies potential investigator sites.
3.Performs comprehensive site management activities. Provides consultative services to site personnel by coordinat ing and disseminating all pertinent data regarding study protocols, Case Report Forms, and FDA/ICH GCP guidelines4.Helps to define quality standards within the project team.
Conducts Prestudy Monitoring visits. Reviews study plans with clinical investigators and evaluates clinical sites to ensure that they meet all study parameters and all FDA and GCP guidelines.
5.Conducts Site Initiation visits. Reviews and explains study protocols with clinical investigators and clinical site staff. Serves as consultant to site personnel on all sponsor?related SOPs and regulatory requirements.
6.Conducts Interim Monitoring visits. Reviews source documents, CRFs, regulatory documents, Informed Consents, Investigational Product, and clinical supply accountability. Ensures all Adverse Events have been documented and reported according to FDA
regulations and sponsor protocols. Provides feedback and training to site personnel as needed.
7.Conducts CloseOut visits. Retrieves and reconciles all study supplies. Archives study documentation and prepares the clinical site for any potential audits.
8 Produces timely and comprehensive visit and status reports with minimal corrections/rewrites.
9 Within International collection of high quality critical documents and completion of ethics committee and regulatory submissions as applicable.
10 Completes all other assignments given by management or as business needs require.
KEY SKILLS &BEHAVIORS
1 List 3?5 key skills and/or behaviors required to perform this job successfully.
2 Solid knowledge of ICHGCP and applicable regulatory guidelines. Solid clinical research and monitoring knowledge base.
3 Demonstrated ability to provide consultative services to Investigators and site personnel.
4 Good communication skills with ability to relay pertinent information to site personnel and study team.
JOB RESPONSIBILITIES
1.List the primary responsibilities(5-7), in order of importance to the business.
2.Identifies potential investigator sites.
3.Performs comprehensive site management activities. Provides consultative services to site personnel by coordinat ing and disseminating all pertinent data regarding study protocols, Case Report Forms, and FDA/ICH GCP guidelines4.Helps to define quality standards within the project team.
Conducts Prestudy Monitoring visits. Reviews study plans with clinical investigators and evaluates clinical sites to ensure that they meet all study parameters and all FDA and GCP guidelines.
5.Conducts Site Initiation visits. Reviews and explains study protocols with clinical investigators and clinical site staff. Serves as consultant to site personnel on all sponsor?related SOPs and regulatory requirements.
6.Conducts Interim Monitoring visits. Reviews source documents, CRFs, regulatory documents, Informed Consents, Investigational Product, and clinical supply accountability. Ensures all Adverse Events have been documented and reported according to FDA
regulations and sponsor protocols. Provides feedback and training to site personnel as needed.
7.Conducts CloseOut visits. Retrieves and reconciles all study supplies. Archives study documentation and prepares the clinical site for any potential audits.
8 Produces timely and comprehensive visit and status reports with minimal corrections/rewrites.
9 Within International collection of high quality critical documents and completion of ethics committee and regulatory submissions as applicable.
10 Completes all other assignments given by management or as business needs require.
KEY SKILLS &BEHAVIORS
1 List 3?5 key skills and/or behaviors required to perform this job successfully.
2 Solid knowledge of ICHGCP and applicable regulatory guidelines. Solid clinical research and monitoring knowledge base.
3 Demonstrated ability to provide consultative services to Investigators and site personnel.
4 Good communication skills with ability to relay pertinent information to site personnel and study team.
公司介绍
Established in 1985, Theorem Clinical Research is one of the industry’s leading full-service, global CROs. Theorem provides core CRO services for Phases I to IV, but with niche business units in the areas of Technical Services, Medical Device and Pharmaceutics.
So what makes us different? Theorem can manage even the most complex project--from study design to product launch and beyond. Our clients see us as “the right size” CRO—big enough to successfully manage your large global trials, but with a personalized service level you might associate with a smaller organization. And we execute with speed, flexibility and an attention to detail that drives high-quality performance. Additionally, we have unique strengths in Asia Pacific and Latin America.
Our comprehensive clinical service offering includes the following:
? Project Management
? Clinical Monitoring*
? Clinical Data Management*
? Regulatory Affairs*
? Clinical Quality Assurance
? Safety Surveillance/Pharmacovigilance*
? Biometrics*
? Clinical Writing
? Investigator Agreements
? Medical Affairs
? Patient Recruitment
The Theorem Clinical Research name is new. But it is built on a long history of delivering exceptional services and support for all phases of clinical research. Before launching in 2011, Theorem Clinical Research operated for nearly two decades as Omnicare Clinical Research under the Omnicare, Inc. parent company. Dating back to the late 1990s, Omnicare Inc. acquired several smaller CROs—including Coromed and IBAH—and launched Omnicare Clinical Research in the year 2000.
Today, we have grown into a global organization with 900+ employees located throughout 27 countries. As our story continues to unfold, one factor remains constant: our people are committed to our clients and their success. For that reason, we strive to enhance our business on an ongoing basis. Whether it’s by opening a new office location, implementing a new technology, or maximizing a strategic new partnership, Theorem Clinical Research understands how to meet your evolving drug development needs.
So what makes us different? Theorem can manage even the most complex project--from study design to product launch and beyond. Our clients see us as “the right size” CRO—big enough to successfully manage your large global trials, but with a personalized service level you might associate with a smaller organization. And we execute with speed, flexibility and an attention to detail that drives high-quality performance. Additionally, we have unique strengths in Asia Pacific and Latin America.
Our comprehensive clinical service offering includes the following:
? Project Management
? Clinical Monitoring*
? Clinical Data Management*
? Regulatory Affairs*
? Clinical Quality Assurance
? Safety Surveillance/Pharmacovigilance*
? Biometrics*
? Clinical Writing
? Investigator Agreements
? Medical Affairs
? Patient Recruitment
The Theorem Clinical Research name is new. But it is built on a long history of delivering exceptional services and support for all phases of clinical research. Before launching in 2011, Theorem Clinical Research operated for nearly two decades as Omnicare Clinical Research under the Omnicare, Inc. parent company. Dating back to the late 1990s, Omnicare Inc. acquired several smaller CROs—including Coromed and IBAH—and launched Omnicare Clinical Research in the year 2000.
Today, we have grown into a global organization with 900+ employees located throughout 27 countries. As our story continues to unfold, one factor remains constant: our people are committed to our clients and their success. For that reason, we strive to enhance our business on an ongoing basis. Whether it’s by opening a new office location, implementing a new technology, or maximizing a strategic new partnership, Theorem Clinical Research understands how to meet your evolving drug development needs.